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https://www.readbyqxmd.com/read/28640161/combined-data-of-intravaginal-prasterone-against-vulvovaginal-atrophy-of-menopause
#1
Fernand Labrie, David F Archer, Céline Martel, Mario Vaillancourt, Marlene Montesino
OBJECTIVE: To analyze the effects of intravaginal prasterone obtained in the three randomized clinical studies performed in postmenopausal women suffering from moderate to severe (MS) dyspareunia due to vulvovaginal atrophy (VVA). METHODS: In three independent 12-week prospective, randomized, double-blind, and placebo-controlled clinical studies, the effect of daily intravaginal 0.50% (6.5 mg) prasterone was examined on four co-primary objectives in women having MS pain during sexual activity (dyspareunia), identified as their most bothersome symptom (MBS) of VVA at baseline...
June 19, 2017: Menopause: the Journal of the North American Menopause Society
https://www.readbyqxmd.com/read/28640158/vasomotor-symptoms-are-associated-with-depressive-symptoms-in-community-dwelling-older-women
#2
Berihun M Zeleke, Robin J Bell, Baki Billah, Susan R Davis
OBJECTIVE: To assess the prevalence of, and factors associated with, moderate-to-severe depressive symptoms in community-dwelling older Australian women. METHODS: A questionnaire-based, cross-sectional study was conducted amongst community-dwelling older women. Participants were recruited between April and August 2014 from a national database based on the electoral roll. Depressive symptoms were assessed by the Beck Depression Inventory-II (BDI-II) tool. Vasomotor symptoms (VMS), vulvovaginal atrophy (VVA), and pelvic floor symptoms were assessed using validated questionnaires...
June 19, 2017: Menopause: the Journal of the North American Menopause Society
https://www.readbyqxmd.com/read/28608667/dynamic-quadripolar-radiofrequency-treatment-of-vaginal-laxity-menopausal-vulvo-vaginal-atrophy-12-month-efficacy-and-safety
#3
Franco Vicariotto, Francesco DE Seta, Valentina Faoro, Mauro Raichi
BACKGROUND: Twelve-month extension of a previous spontaneous exploratory study investigating safety and efficacy of a new low-energy dynamic quadripolar radiofrequency (DQRF) device in: A) premenopausal women with symptoms of vaginal laxity, with special reference to dysuria, urinary incontinence and unsatisfactory sexual life (vaginal laxity arm of the study); B) postmenopausal women with vulvovaginal atrophy/genitourinary syndrome of menopause (VVA/GSM) and VVA/GSM-related symptoms (VVA/GSM arm of the study)...
August 2017: Minerva Ginecologica
https://www.readbyqxmd.com/read/28562130/effects-of-ospemifene-on-vaginal-epithelium-of-post-menopausal-women
#4
Stefania Alvisi, Maurizio Baldassarre, Valentina Martelli, Giulia Gava, Renato Seracchioli, Maria Cristina Meriggiola
Ospemifene is a selective estrogen receptor modulator used for the treatment of vulvo-vaginal atrophy (VVA) in post-menopausal women. No direct evidence of its effects on histological features of the human vagina has been reported. To evaluate the effects of ospemifene on histological parameters, glycogen content, proliferation, and estrogen receptor α expression (ERα) of vaginal epithelium in post-menopausal women. Thirty-two post-menopausal women undergoing surgical procedures were enrolled. Sixteen subjects taking ospemifene at the time of inclusion (OSP) were compared to 16 subjects not taking any hormone (CTL)...
May 31, 2017: Gynecological Endocrinology
https://www.readbyqxmd.com/read/28539177/relationship-between-changes-in-vulvar-vaginal-atrophy-and-changes-in-sexual-functioning
#5
JoAnn V Pinkerton, Andrew G Bushmakin, Barry S Komm, Lucy Abraham
OBJECTIVE: Conjugated estrogens/bazedoxifene (CE/BZA) has demonstrated benefit in vulvar-vaginal atrophy (VVA, part of genitourinary syndrome of menopause) and the sexual function domain of the Menopause-specific Quality of Life (MENQOL) questionnaire. The study's objective was to determine the relationship of VVA symptoms and clinical parameters with MENQOL sexual functioning in postmenopausal women receiving VVA treatment. STUDY DESIGN: Post hoc analysis data were derived from the 12-week SMART-3 trial, which evaluated CE/BZA's effect on VVA in nonhysterectomized postmenopausal women (aged 40-65 years) experiencing one or more moderate to severe VVA symptoms (dryness, itching/irritation, pain with intercourse) and vaginal pH>5...
June 2017: Maturitas
https://www.readbyqxmd.com/read/28503946/fractional-co2-laser-therapy-a-new-challenge-for-vulvovaginal-atrophy-in-postmenopausal-women
#6
G P Siliquini, V Tuninetti, V E Bounous, F Bert, N Biglia
OBJECTIVE: To evaluate the effects of CO2 laser in the treatment of vulvovaginal atrophy (VVA) in postmenopausal women. METHODS: VVA was assessed in 87 postmenopausal women (mean age 58.6 ± 6.9 years) before and after the treatment. The protocol consisted of three monthly treatments and included the treatment of vulva. Subjective measures included VAS (Visual Analog Scale) both for vaginal dryness and dyspareunia; DIVA (Day-by-day Impact of Vaginal Aging); a questionnaire on treatment satisfaction and one about the degree of pain during the procedure...
May 15, 2017: Climacteric: the Journal of the International Menopause Society
https://www.readbyqxmd.com/read/28490209/retrospective-analysis-in-46-women-with-vulvovaginal-atrophy-treated-with-ospemifene-for-12-weeks-improvement-in-overactive-bladder-symptoms
#7
Michele Carlo Schiavi, Marzio Angelo Zullo, Pierangelo Faiano, Ottavia D'Oria, Giovanni Prata, Vanessa Colagiovanni, Andrea Giannini, Chiara Di Tucci, Giorgia Perniola, Violante Di Donato, Marco Monti, Ludovico Muzii, Pierluigi Benedetti Panici
AIMS: The aim of this study was to assess the effectiveness and safety of ospemifene in the improvement of overactive bladder (OAB) symptoms in postmenopausal women affected by vulvovaginal atrophy (VVA). METHODS: Forty-six postmenopausal patients affected by VVA with OAB syndrome were enrolled for the study. All patients received Ospemifene 60 mg for 12 weeks. Clinical examination, 3-day voiding diary, urodynamic testing, ultrasound measurement of endometrial and bladder wall thickness (BWT) and the Vaginal Health Index (VHI) were performed at baseline and 12 weeks...
May 11, 2017: Gynecological Endocrinology
https://www.readbyqxmd.com/read/28479073/-macroscopic-description-of-placental-vascular-anastomoses-after-dye-injection-for-the-comprehension-of-monochorionic-pregnancy-complications
#8
A Atallah, P-A Bolze, A Buenerd, S Marino, J Massardier, P Gaucherand, M Massoud
OBJECTIVES: The aim of the study is to compare placental monochorionic angioarchitecture complicated with twin-oligohydramnios-polyhydramnios sequence (TOPS), twin anemia polycythemia sequence (TAPS), twin reversed arterial perfusion (TRAP) and selective intra uterine growth restriction (sIUGR) to normal uneventful monochorionic placenta. METHODS: Between December 2012 and December 2015, monochorionic placenta has been studied at the multiple pregnancy care center of the Femme-Mère-Enfant Hospital in Lyon...
May 2017: Gynecologie, Obstetrique, Fertilite & Senologie
https://www.readbyqxmd.com/read/28419068/visual-improvements-in-vaginal-mucosa-correlate-with-symptoms-of-vva-data-from-a-double-blind-placebo-controlled-trial
#9
James A Simon, David F Archer, Risa Kagan, Brian Bernick, Shelli Graham, Ginger D Constantine, Sebastian Mirkin
OBJECTIVE: To evaluate the response of the vaginal mucosa with TX-004HR and its correlation with vulvar and vaginal atrophy (VVA) symptoms, and whether visual examination is a useful measure for assessing VVA. METHODS: REJOICE was a 12-week, phase 3, multicenter, randomized, double-blind, placebo-controlled study of a vaginal, muco-adhesive, 17β-estradiol softgel capsule (TX-004HR 4, 10, and 25 μg) in postmenopausal women with VVA and moderate-to-severe dyspareunia...
April 17, 2017: Menopause: the Journal of the North American Menopause Society
https://www.readbyqxmd.com/read/28398023/clinical-profile-of-women-with-vva-who-are-not-candidates-for-local-vaginal-oestrogen-therapy
#10
Rossella E Nappi, Filippo Murina, Giuseppina Perrone, Paola Villa, Nicoletta Biglia
Vulvar and vaginal atrophy (VVA) is a chronic medical condition in postmenopausal women, which is predominantly due to a permanent cessation of ovarian oestrogen production. Current available treatment options for VVA are over-the-counter (OTC) symptomatic relief products or local oestrogen therapy (LET) aiming to treat this underlying atrophic condition. Recent surveys indicated that these products decrease sexual spontaneity, are messy and indiscrete. Ospemifene is an oral daily drug, which has proven to treat vaginal dryness and dyspareunia effectively...
April 10, 2017: Minerva Ginecologica
https://www.readbyqxmd.com/read/28388560/galnt6-expression-enhances-aggressive-phenotypes-of-ovarian-cancer-cells-by-regulating-egfr-activity
#11
Tzu-Chi Lin, Syue-Ting Chen, Min-Chuan Huang, John Huang, Chia-Lang Hsu, Hsueh-Fen Juan, Ho-Hsiung Lin, Chi-Hau Chen
Ovarian cancer is the most lethal of the gynecologic malignancies. N-acetylgalactosaminyltransferase 6 (GALNT6), an enzyme that mediates the initial step of mucin type-O glycosylation, has been reported to regulate mammary carcinogenesis. However, the expression and role of GALNT6 in ovarian cancer are still unclear. Here we showed that high GALNT6 expression correlates with increased recurrence, lymph node metastasis, and chemoresistance in ovarian endometrioid and clear cell carcinomas; and higher GALNT6 levels are significantly associated with poorer patient survivals...
March 28, 2017: Oncotarget
https://www.readbyqxmd.com/read/28364869/a-vaginal-estradiol-softgel-capsule-tx-004hr-has-negligible-to-very-low-systemic-absorption-of-estradiol-efficacy-and-pharmacokinetic-data-review
#12
REVIEW
James A Simon, David F Archer, Ginger D Constantine, James H Pickar, Julia M Amadio, Brian Bernick, Shelli Graham, Sebastian Mirkin
This paper reviews the efficacy, safety, and systemic absorption of estradiol with TX-004HR, an investigational, low-dose 17β-estradiol vaginal softgel capsule, designed to treat vulvar and vaginal atrophy (VVA) in postmenopausal women, with an improved user experience. In phase 2 (NCT02449902) and phase 3 REJOICE (NCT02253173) studies, TX-004HR significantly improved the proportions of vaginal superficial and parabasal cells and vaginal pH, and in the phase 3 study decreased the severity of dyspareunia, vaginal dryness, and vulvar and/or vaginal itching or irritation...
May 2017: Maturitas
https://www.readbyqxmd.com/read/28355090/consistency-of-effect-with-a-low-dose-estradiol-vaginal-capsule-tx-004hr-evaluating-improvement-in-vaginal-physiology-and-moderate-to-severe-dyspareunia-in-subgroups-of-postmenopausal-women
#13
Ginger D Constantine, Celine Bouchard, James H Pickar, David F Archer, Shelli Graham, Brian Bernick, Sebastian Mirkin
BACKGROUND: The 12-week, randomized, double-blind, placebo-controlled, multicenter, phase 3 REJOICE trial demonstrated that TX-004HR, an investigational, applicator-free, low-dose vaginal softgel capsule containing solubilized 17β-estradiol, effectively and rapidly treats symptoms of vulvar and vaginal atrophy (VVA) with negligible to very low systemic absorption. The aim of this analysis was to assess whether the efficacy of TX-004HR varies with age, body mass index (BMI), uterine status, pregnancy status, and vaginal delivery...
June 2017: Journal of Women's Health
https://www.readbyqxmd.com/read/28323042/comparison-of-intravaginal-6-5mg-0-50-prasterone-0-3mg-conjugated-estrogens-and-10%C3%AE-g-estradiol-on-symptoms-of-vulvovaginal-atrophy
#14
REVIEW
David F Archer, Fernand Labrie, Marlene Montesino, Céline Martel
The objective is to compare the effect of intravaginal dehydroepiandrosterone (DHEA, prasterone), conjugated equine estrogens (CEE) and estradiol (E2) on moderate to severe dyspareunia and/or vaginal dryness. In a review of available data, independent prospective, randomized, double-blind and placebo-controlled Phase III 12-week clinical trials involved daily administration of 6.5mg (0.50%) prasterone, daily (21days on/7days off) 0.3mg CEE, twice weekly 0.3mg CEE or 10μg E2 daily for 2 weeks followed by twice weekly for 10 weeks...
March 18, 2017: Journal of Steroid Biochemistry and Molecular Biology
https://www.readbyqxmd.com/read/28277131/macro-regional-variation-in-attitudes-toward-and-experiences-of-vulvar-and-vaginal-atrophy-among-italian-post-menopausal-women-a-post-hoc-analysis-of-revive-survey-data
#15
Rossella E Nappi, Martire Particco, Nicoletta Biglia, Angelo Cagnacci, Costantino Di Carlo, Stefano Luisi, Anna Maria Paoletti
Italian participants in the European REVIVE survey reported that vaginal and vulvar atrophy (VVA) impaired various aspects of their lives, notably the ability to enjoy sex. The aim of the present study was to explore regional differences in knowledge, experiences, and treatment of VVA in the Italian REVIVE sample (n = 1000), which was analyzed according to region of residence. While many respondents were unfamiliar with the VVA condition, most could relate their VVA symptoms to the menopause. The rate of diagnosis of VVA was twice as high in Central Italy as in the North-East...
February 21, 2017: Gynecological Endocrinology
https://www.readbyqxmd.com/read/28275615/cannulation-techniques-for-extracorporeal-life-support
#16
REVIEW
Evgeny Pavlushkov, Marius Berman, Kamen Valchanov
The article reviews cannulation strategy for different modes of extracorporeal life support. Technical aspects, pitfalls and complications are discussed for central and peripheral extracorporeal membrane oxygenation (VA, VV, VAV, VVA), biventricular assist device support and extracorporeal CO2 removal.
February 2017: Annals of Translational Medicine
https://www.readbyqxmd.com/read/28267367/systematic-indirect-comparison-of-ospemifene-versus-local-estrogens-for-vulvar-and-vaginal-atrophy
#17
N Bruyniks, N Biglia, S Palacios, A O Mueck
In the absence of a direct head-to-head study, we performed an indirect historical comparison of ospemifene 60 mg (Senshio(®)) vs. local vaginal estrogens in moderate or severe vulvar and vaginal atrophy (VVA). A literature search was carried out of clinical efficacy/safety trials of local vaginal estrogens in VVA approved in Europe. For efficacy comparison, studies had to be placebo-controlled and of 12 weeks' duration. For safety comparison, studies had to be ≥40 weeks' duration. Efficacy endpoints were the difference between active and placebo in change from baseline to week 12 for symptoms, vaginal pH, and maturation value (MV)...
March 7, 2017: Climacteric: the Journal of the International Menopause Society
https://www.readbyqxmd.com/read/28202320/the-women-s-empower-survey-identifying-women-s-perceptions-on-vulvar-and-vaginal-atrophy-and-its-treatment
#18
Sheryl A Kingsberg, Michael Krychman, Shelli Graham, Brian Bernick, Sebastian Mirkin
INTRODUCTION: Vulvar and vaginal atrophy (VVA) affects up to two thirds of postmenopausal women, but most symptomatic women do not receive prescription therapy. AIM: To evaluate postmenopausal women's perceptions of VVA and treatment options for symptoms in the Women's EMPOWER survey. METHODS: The Rose Research firm conducted an internet survey of female consumers provided by Lightspeed Global Market Insite. Women at least 45 years of age who reported symptoms of VVA and residing in the United States were recruited...
March 2017: Journal of Sexual Medicine
https://www.readbyqxmd.com/read/28202319/the-women-s-empower-survey-women-s-knowledge-and-awareness-of-treatment-options-for-vulvar-and-vaginal-atrophy-remains-inadequate
#19
Michael Krychman, Shelli Graham, Brian Bernick, Sebastian Mirkin, Sheryl A Kingsberg
INTRODUCTION: Postmenopausal women's knowledge about vulvar and vaginal atrophy (VVA) and available treatment options has historically been inadequate. Recent direct-to-consumer marketing and educational efforts would have been expected to increase awareness and treatment options. AIM: To compare results of the Women's EMPOWER survey with other available VVA surveys to assess progress in women's understanding and approaches to treatment of VVA. METHODS: The Women's EMPOWER survey, an internet-based survey of US women with VVA symptoms, assessed women's awareness of VVA and their behaviors and attitudes associated with symptom treatment...
March 2017: Journal of Sexual Medicine
https://www.readbyqxmd.com/read/28195995/patient-acceptability-and-satisfaction-with-a-low-dose-solubilized-vaginal-estradiol-softgel-capsule-tx-004hr
#20
Sheryl A Kingsberg, Robin Kroll, Irwin Goldstein, Harvey Kushner, Brian Bernick, Shelli Graham, Sebastian Mirkin, Ginger D Constantine
OBJECTIVE: TX-004HR is an investigational, muco-adhesive, vaginal, softgel capsule containing low-dose, solubilized, 17β-estradiol designed to treat postmenopausal vulvar and vaginal atrophy (VVA) and improve user experience without an applicator and less mess. METHODS: As part of the 12-week, placebo-controlled, double-blind, phase 3 REJOICE trial evaluating the efficacy/safety of 4-, 10-, and 25-μg TX-004HR in 764 postmenopausal women with VVA, a five-question product survey was administered...
February 13, 2017: Menopause: the Journal of the North American Menopause Society
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